Snacking product with capsaicin or analogue thereof

ABSTRACT

A zero-calorie to near-zero-calorie snacking product that, when consumed, provides a feeling of fullness prior to absorption of energy-providing food, i.e., pre-absorptive satiation is disclosed. The snacking product is based on the stimulation of vagal nerve endings in the gastro-intestinal tract by encapsulated capsaicin. The encapsulation of capsaicin avoids the burning sensation in the mouth which may be objectionable to some consumers.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 61/779,844, filed on Mar. 13, 2013, which is incorporatedherein by reference in its entirety for all purposes.

BACKGROUND

Weight loss and dieting are constant struggles for many people. Appetitesuppression is one method of controlling food intake, thereby reducingcalorie consumption. Appetite suppression is therefore an effectivemethod of weight loss.

Encapsulated capsaicin has the ability to stimulate the vagal nerveendings in the gastro-intestinal tract, thereby causing appetitesuppression. Currently-used appetite suppressants include systemic drugswhich have many side effects such as dependency, resistance, insomnia,drowsiness, irritability, and/or depression. Accordingly, there is ademand for an appetite suppressant composition which is safe, effective,and without harmful side effects.

SUMMARY

A method for suppressing hunger comprising stimulating vagal nerveendings in the gastrointestinal tract. An additional embodiment is amethod for suppressing hunger comprising stimulating vagal nerve endingsin the gastrointestinal tract wherein the vagal nerve endings expressthe transient receptor potential cation channel subfamily receptor Vmember 1 (TRPV1) receptor. A further embodiment is a method forsuppressing hunger comprising stimulating vagal nerve endings in thegastrointestinal tract wherein the vagal nerve endings express thetransient receptor potential cation channel subfamily receptor V member1 (TRPV1) receptor and the cholecystokinin (CCK) receptor.

A method for suppressing hunger comprising stimulating vagal nerveendings in the gastrointestinal tract wherein the stimulation of vagalnerve endings is done by capsaicin, or a capsaicin analogue, or acombination thereof. A further embodiment is a method for suppressinghunger comprising stimulating vagal nerve endings in thegastrointestinal tract wherein the stimulation of vagal nerve endings isdone by encapsulated capsaicin, or a capsaicin analogue, or acombination thereof. An additional embodiment is a method forsuppressing hunger comprising stimulating vagal nerve endings in thegastrointestinal tract wherein the stimulation of vagal nerve endings isdone by micro-encapsulated capsaicin, or a capsaicin analogue, or acombination thereof. Another embodiment is a method for suppressinghunger comprising stimulating vagal nerve endings in thegastrointestinal tract wherein the stimulation of vagal nerve endings isdone by administering micro-encapsulated capsaicin, or a capsaicinanalogue, or a combination thereof, additionally in combination withKorean Pine Oil.

A snacking product containing a flavor system which stimulates the vagalnerve endings in the gastrointestinal tract and provides pre-absorptivesatiation. A further embodiment is a snacking product containing aflavor system which stimulates the vagal nerve endings in thegastrointestinal tract and provides pre-absorptive satiation in whichthe flavor system comprises encapsulated capsaicin. Another embodimentis a snacking product containing a flavor system which stimulates thevagal nerve endings in the gastrointestinal tract and providespre-absorptive satiation in which the flavor system comprisesencapsulated capsaicin and Korean Pine Oil. An additional embodiment isa snacking product containing a flavor system which stimulates the vagalnerve endings in the gastrointestinal tract and provides pre-absorptivesatiation wherein the product is an energy drink, an energy bar, adietary supplement, a capsule, a pill, or a lozenge. Another embodimentis a snacking product containing a flavor system which stimulates thevagal nerve endings in the gastrointestinal tract and providespre-absorptive satiation wherein the product is located in a screw capand is released upon opening of the screw cap.

A method for producing a snacking product containing a flavor systemwhich stimulates the vagal nerve endings in the gastrointestinal tractand provides pre-absorptive satiation comprising combining said flavorsystem with other ingredients of a snacking product.

BRIEF DESCRIPTION OF FIGURES

FIG. 1 is a graph of prospective food consumption measured by a visualanalogue test over time.

FIG. 2 is a graph of desire to eat as measured by a visual analogue testover time.

FIG. 3 is a graph of hunger as measured by a visual analogue test overtime.

FIG. 4 is a graph of satiety as measured by a visual analogue test overtime.

FIG. 5 is a graph of fullness as measured by a visual analogue test overtime.

FIG. 6 is a distribution plot of desire to eat ratings, wherein eachpoint represents an individual participant.

FIG. 7 is a graph of desire to eat change from baseline.

FIG. 8 is a graph of desire to eat change from the baseline separated bygender.

FIG. 9 is a graph of food intake at lunch.

FIG. 10 is a correlation between food intake and desire to eat, whereinthe left graph is the placebo; the middle chart is capsaicin only; andthe right chart is capsaicin and satiety drink.

DETAILED DESCRIPTION

The feeling of non-absorptive satiation is mediated by the vagal nerveendings. Vagal nerve endings are specifically stimulated bycholecystokinine (CCK) as a result of the presence of food in thestomach and in the small intestine. CCK is a peptide hormone responsiblefor stimulating the digestion of fat and protein, and also acts as ahunger suppressant. Another effect of CCK is that it enhances thesatiation response coming from the mechanical distension of thegastro-intestinal (GI) tract, typically after food intake. Vagal nervefibers that express CCK-receptors also express the transient receptorpotential cation channel subfamily V member 1 (TRPV1) receptor, alsoknown as the capsaicin receptor. Capsaicin is the active component ofchili peppers and produces a burning sensation in many tissues withwhich it comes into contact. Encapsulated capsaicin has the ability tostimulate the vagal nerve endings in the gastro-intestinal tract.

An appetite suppressant composition having the ability to provide afeeling of pre-absorptive satiation, i.e., before energy-providing foodis absorbed is described herein. An embodiment is an appetitesuppressant composition having the ability to reduce body mass index,and cholesterol, triglycerides, glucose, and insulin levels. Anotherembodiment is an appetite suppressant composition which increases thebioavailability of the appetite suppressant composition components.

An embodiment is an appetite suppressant composition which impacts thevagal nerve endings typically activated by cholecystokinine (CCK) togenerate pre-absorptive satiation. Another embodiment is an appetitesuppressant composition which would increase the satiation effect ofencapsulated capsaicin through a combination with material that is basedon food fibers or the like which in itself results in a feeling offullness and satiation. A flavor system that provides a delightful tasteand smell, but consecutively reduces the desire for such foodconsumption (i.e., sensory specific satiety) is envisioned. The term“flavor system,” as used herein, includes all of the flavors orflavor-enhancing components in the composition.

A composition containing an encapsulated capsaicin-based flavor systemfor suppressing the appetite has been developed. In one form, theappetite suppressant composition can be in the form of a snackingproduct, beverage, capsule, pill, lozenge, or other suitable form.

The appetite suppressant composition in one form includes encapsulatedcapsaicin. In an embodiment, the appetite suppressant composition caninclude and/or consist of at least about 0.1% (w/v) encapsulatedcapsaicin. Another embodiment is a method of suppressing appetiteincluding administering an appetite suppressant composition. Anembodiment relates to a method of reducing total cholesterol, glucose,insulin, and triglyceride levels including administering an appetitesuppressant composition. Another embodiment relates to a method ofcreating a feeling of satiety including administering the appetitesuppressant. One form of the composition is designed to be ingested andcan be formulated into a snacking product.

As used herein, the term “capsaicin” includes natural capsaicin,capsaicinoids, and synthetic capsaicin. Capsaicin is derived from thefruits of the Solanaceae family and the Capsicum genus. The crudeisolate of the fruit is called capsicum oleoresin and contains over 100chemicals. A further extraction process results in “natural capsaicin.”

As used herein, the term “natural capsaicin” contains up to 5 relatedmolecules which are capsaicin, dihydrocapsaicin, nordihydrocapsaicin,homocapsaicin, and homodihydrocapsaicin. Most of this “naturalcapsaicin” is made of capsaicin and dihydrocapsaicin. “Capsaicin,” alsoknown as N-(4-hydroxy-3-methoxybenzyl)-8-methylnon-6-enamide ortrans-8-Methyl-N-vanillylnon-6-enamide, has CAS Registry Number 404-86-4and Molecular Formula: C₁₈H₂₇NO₃. Capsaicin has a molecular weight of305.41 g/mol⁻¹. “Dihydrocapsaicin,” also known asN-[(4-Hydroxy-3-methoxy-phenyl) methyl]-8-methyl-nonanamide, has CASRegistry Number 19408-84-5 and Molecular Formula C₁₈H₂₉NO₃.Dihydrocapsaicin has a molecular weight of 307.43 g/mol⁻¹.

As used herein, the term “capsaicinoids” includes compounds with actionlike capsaicin. These include natural and synthetic products. An exampleis Nonivamide (N-[(4-hydroxy-3-methoxyphenyl)methyl]nonanamide), alsoknown as Pelargonic acid vanillylamide (PAVA), which has CAS RegistryNumber 2444-46-4 and Molecular Formula C₁₇H₂₇NO₃. Nonivamide has amolecular weight of 293.4 g/mol⁻¹. Also envisioned are capsinoids suchas capsiate, dihydrocapsiate, nordihydrocapsiate, palvanil, etc.

“Synthetic capsaicin” can be manufactured synthetically. It can be soldas a capsaicin substitute, as it also affects the capsaicin-sensitiveprimary afferent fibers just like capsaicin.

Other ingredients which have similar functions to capsaicin, such asallyl isothiocyanate (the compound responsible for the pungent taste ofmustard, horseradish, and wasabi), piperine (the compound responsiblefor the pungency of black and white pepper), and ginger (a mixture ofzingerone, shogaols, and gingerols) can be encapsulated as well.Similarly, caffeine may be co-encapsulated along with capsaicin oringredients which have similar functions to capsaicin.

In one embodiment, the snacking product containing a flavor system whichstimulates the vagal nerve endings in the gastrointestinal tractproviding pre-absorptive satiation is an energy drink, energy bar, ordietary supplement.

As used herein, the term “dietary supplement” refers to a supplementsuitable for oral consumption that is administered orally. In preferredembodiments, the dietary supplement is in the form of capsules (e.g.,those meant to be swallowed or chewed), tablets (e.g., those meant to beswallowed or chewed), powders (e.g., the powder can be added to water,milk, or another liquid), liquids (e.g., either in ready to drink formor suitable for dilution in another beverage), or nutritionalfoodstuffs. For example, the dietary supplement can be in the form ofnutritional bars (e.g., meal or snack bars), cookies, candies (e.g.,taffies, caramels, jellies, chocolate melt-aways, chews such as fruitchews, gums), syrups, or beverages (e.g., ready to drink or in the formof concentrates or powders).

The effect of the components of the appetite suppressant composition inone form are believed to immediately produce and provide a feeling ofpre-absorptive satiation, i.e., before energy-providing food isabsorbed. The appetite suppressant composition in one form is alsobelieved to reduce body mass index, and cholesterol, triglycerides,blood glucose, and insulin levels.

The appetite suppressant composition further is believed to impact theTRPV1 receptors at vagal nerve endings that are also sensitive to CCK inthe gastrointestinal tract. The encapsulation of capsaicin avoids theburning sensation in the mouth which may be objectionable to someconsumers. The capsules dissolve in the acidic environment of thestomach but not mechanically through chewing. This allows release of thecapsaicin directly into the small intestine. Once in the smallintestine, capsaicin activates TRPV1 receptors at vagal nerve endings.

The capsaicin product may be coated or encapsulated. The coating orencapsulation may be performed such that the coated or encapsulatedcapsaicin product comprises a micro-sized spherical particle. Forexample, according to certain embodiments, the coated or encapsulatedcapsaicin product may comprise micro-sized spherical particles having asize range of 125 microns to 400 microns. The material used to coat orencapsulate the capsaicin product may comprise a digestible matrix thatis degraded in the digestive and/or intestinal tract of the individualafter the composition is orally consumed by the individual. In certainembodiments, the material used to coat or encapsulate the capsaicinproduct may comprise a hydrogenated vegetable oil matrix, ahydroxypropyl methyl cellulose, or a combination thereof. According toother embodiments, the capsaicin product may be coated or encapsulatedby coating or encapsulating the capsaicin product with a hydrogenatedvegetable oil matrix or granulated with the hydroxypropyl methylcellulose. Enteric coating, sustained release coating, and inclusioncomplex formation may also be used. The coating or encapsulation of thecapsaicin product may enable a consumer to avoid an objectionableburning sensation in the mouth.

A second component that would increase the satiation effect ofencapsulated capsaicin would be the combination with material that isbased on food fibers or the like which in itself results in a feeling offullness and satiation.

A third component would be the presence of a flavor system that providesa delightful taste and smell, but consecutively reduces the desire forsuch food consumption (sensory specific satiety). All these componentscould be incorporated into the snacking product that should and couldhave zero or near zero calories.

In one embodiment, the appetite suppressant composition can includeabout 0.01% to 10% (w/v) capsaicin. In another embodiment, the appetitesuppressant composition can include about 0.05% to 6% (w/v) capsaicin.The appetite suppressant composition can still further include about0.1% to 1.5% (w/v) capsaicin. In another embodiment, the appetitesuppressant composition can include at least about 0.1% (w/v) capsaicin.

The encapsulated capsaicin may be manufactured by combining allingredients in a form suitable for oral administration, and preferablyas a capsule or tablet. The encapsulated capsaicin may be encapsulated(such as in a coating of hard gelatin) for oral administration. Suchtechniques are well known in the art. See, e.g., Baker, Controlledrelease of biologically active agents, John Wiley & Sons, (1986). Inertfillers may also be present in oral (e.g., capsule or tablet) form.

Administration includes not only single dosage forms, but also multipledosage forms used in conjunction with one another. For instance, in oneembodiment, the dietary supplement is a capsule (e.g., containingencapsulated capsaicin). In another embodiment, the dietary supplementis an energy drink in conjunction with encapsulated capsaicin located ina screw cap that is released upon opening of the screw cap and consumedwith the energy drink.

The regimen of consumption can vary according to the form of the dietarysupplement. When formulated as capsules, the encapsulated capsaicin ispreferably administered one to three times a day, and preferably 45minutes to two hours prior to any given meal. Administration of theencapsulated capsaicin controls calorie intake for a considerable periodof time, including up to 12 hours into the following day. The amount ofencapsulated capsaicin administered is sufficient to suppress appetite.While the oral dosage may contain from 2 mg to 5000 mg (i.e., totalweight of all active ingredients), a single capsule or tablet preferablycontains between 10 and 1000 mg of capsaicin, more preferably between100 and 500 mg of capsaicin, and most preferably between 320 and 380 mgof capsaicin.

Preferably, there is oral consumption of the capsule or tablet form ofdietary supplements over an extended period during the subject'slifetime, preferably daily. While benefits are obtainable after variousmaximum periods of use (e.g., five, ten or twenty years), it ispreferred that oral consumption of the capsule or tablet form of dietarysupplements continues throughout the subject's lifetime. Preferably, thedietary supplement is administered at a safe and effective amount.

The examples explained below are given by way of illustration only andshould not be interpreted as constituting any limitation of the subjectof the present invention.

EXAMPLES Example 1

This example demonstrates that capsaicin activates CCK-sensitive fibersin the gastro-intestinal tract to suppress hunger and that capsaicinpotentiates stomach distension as does CCK. Thus, capsaicin prevents ordecreases feelings of hunger and desire to eat.

Participants performed overnight fasting starting at 10:00 p.m. andrecorded their dinner intake. Participants were restricted to a limitedwater intake, approximately 0.5 L maximum from 9:00 am on. Fourexperimental conditions were tested: (1) Placebo capsule/no distension;(2) Capsaicin capsule/no distension; (3) Placebo capsule/distension; and(4) Capsaicin capsule/distension. “No distension” indicates that thecapsule was taken with the specified amount of water, e.g., 50 ml water.“Placebo capsules” contained no powder. “Capsaicin capsules” contained0.32 g of red pepper. “Distension” indicates that the capsule was takenwith the specified amount of liquid beverage, e.g., 150 ml Thai basilseed drink. Thai basil seed drink is a traditional Thai weight lossinstrument and is mixed with sugar, water and honey.

A Visual analogue scale (VAS) test was administered to measure theattributes of hunger, satisfaction, fullness, desire to eat, andprospective food consumption. A VAS test was administered at 11:00,11:30, 11:45, 12:00, 12:15, 12:30, 1:00, 2:00, 3:00, and 4:00. Thecapsule was swallowed at 11:15 and the participants consumed astandardized lunch containing a sandwich, fruit salad, cookie, and waterat 12:45. Each participant underwent four sessions, separated by atleast 2 days.

Results from this study are depicted in FIGS. 1-5. FIGS. 1-5 are graphsdepicting prospective food consumption, desire to eat, hunger, satiety,and fullness as measured by a visual analogue test over time. Testgroups include placebo with water (pbo water), capsaicin with water (capwater), placebo with Thai basil seed drink (pbo drink), and capsaicinwith Thai basil seed drink (cap drink). Capsaicin alone decreasedprospective food consumption and desire to eat, and increased fullnessbefore lunch. There was no observed effect of capsaicin alone versusplacebo after lunch. The basil seed drink eliminated the capsaicineffects before lunch. Capsaicin alone and the basil seed drink aloneseem to increase fullness to a similar degree but are not additive.There may be differences in prospective food consumption and desire toeat with the basil seed drink versus water after lunch.

Example 2

This example includes ground red pepper alone and in combination withPINNOTHIN™ and CLEARPROTEIN™. PINNOTHIN™ is a commercially-availabledietary supplement for appetite suppression containing Korean pine nutoil which causes the release of satiety hormones such as cholecystokinin(CCK) and glucagon-like peptide 1 (GLP-1). A 2008 study demonstrated a9% reduction in food intake after PINNOTHIN™ treatment. See, e.g.,Hughes et al., The effect of Korean pine nut oil (PinnoThin) on foodintake, feeding behavior and appetite: a double-blind placebo-controlledtrial, LIPIDS HEALTH DIS 7:6 (2008). CLEARPROTEIN™ is a whey proteinsoluble in beverages that provides a positive effect on post-mealmeasures of satiety.

This study utilized a randomized, double-blinded cross-over study designrun at a single research center. The study was conducted at the ConsumerOpinion Center (COC), Richmond, Va., by Celerion, a contract researchorganization.

The participants comprise adult male and female smokers, age 21-65, ingood health. Up to 100 adult smokers were initially recruited forscreening to assure 50 enrolled participants completed the study.Smoking history of at least 6 months of five or less cigarettes per dayor non-daily smokers. Neither gender constituted more than 60% of thetotal number of participants.

The demographics of the study appear in the following tables:

Category N % of Total Gender F  22* 44% M  28** 56% Race White 21 42%Black 24 48% Hispanic  1  2% Other  4  8% *2 participants only completed1 session; 1 participant completed two sessions; 1 participant didn'treturn the pre-dinner and post-dinner ballot ratings **1 participantonly completed 1 session; 2 participants completed two sessions; 1participant didn't return the pre-dinner and post-dinner ballot ratings

AGE N Mean Min Max Median All 50 33.7 22 60 28 Females 22 33.8 22 58 29Males 28 33.6 23 60 27.5

The study was conducted in three (3) Study Sessions with only one (1)Study Session per day. Each Study Session lasted approximately 7-8hours. There was a total of 3 Study Sessions spread over 3non-consecutive days (no more than two (2) days per week perparticipant). The test samples administered in each Study Session wererandomized for all participants. All Study Sessions were completed byeach participant within a 3-week timeframe.

For Session One (1), participants arrived at their appointed day andtime of their study session after overnight abstinence from tobacco use.The nature and purpose of the study was outlined to them. Allprospective participants who agreed to participate were required toread, sign, and date the Informed Consent Form (ICF) before any studyprocedures are performed. The Investigator or his/her designee wasavailable to answer any questions participants may have that Celerionstaff members administering the ICF could not answer. Participants whodeclined to participate at this stage were thanked and asked to leave.

After signing the ICF, each participant was screened for eligibility toparticipate in the study by reviewing inclusion/exclusion (I/E) criteriaand study restrictions and completing a Tobacco Consumption HistoryQuestionnaire and General Health Questionnaire. If participants did notmeet the required screening results range for study participation, theywere excused. An abbreviated review of the I/E criteria and the GeneralHealth Questionnaire was conducted prior to Sessions Two (2) and Three(3) to ensure continued eligibility for the study.

For all Study Sessions, a standardized breakfast was served and theparticipants were asked to complete a visual analog scale (VAS) ratingballot on a computer screen before and after the meal. The participantsremained in the study room for 150 minutes, and were allowed to engagein quiet activities such as reading or watching television. Next, a testsample was administered. Participants were asked to complete the VASrating ballot prior to test sample as well as at designated intervalsfollowing the test sample. After 120 minutes, a standardized test lunchmeal was served with participants permitted to consume ad libitum untilreaching fullness. Following the test meal, the participants completedseveral more VAS rating ballots at designated intervals prior to thesession end. Participants who completed Session One (1) and qualified toparticipate in Sessions Two (2) and Three (3) were asked to return tocontinue the study.

Each participant received each of the three test samples once over thethree Study Sessions in a randomized fashion.

Participants were first introduced to the study procedures and theninstructed by study staff on how to perform the evaluations. Thisincluded reviewing the VAS rating ballot and instructions on how to marktheir ratings on the ballot sheet.

A standardized breakfast was served to all participants at 8:00 am, andthey were instructed to consume all of the breakfast within the allotted15 minute period. VAS ratings were collected before and after eating.Following breakfast, participants remained in the study room for thenext 150 minutes engaging in quiet activities such as reading, watchingtelevision or other appropriate activities. No food was permitted duringthis time. One (1) 8 oz. bottle of water was provided to eachparticipant during this time.

At 11:00 am, each participant provided pre-test VAS ratings followed byadministration of a test sample, which was consumed completely within a5-minute period. The participant then completed VAS ratings ballots at15, 30, 45, 60, and 90 minutes following test sample consumption. Quietactivities were resumed in between ballot completion intervals. One (1)8 oz. bottle of water was permitted prior to lunch. The order of testsample presentation was randomized over the three Study Sessions foreach participant.

At 1:00 pm, each participant was provided pre-meal VAS ratings followedby a standardized lunch. Each participant served themselves onto a platefrom their own individual serving bowl. Participants were instructed totake as much as they like (seconds, thirds, etc.) and eat until full inthe allotted 30 minute period. The serving bowl was weighed before andafter eating (blinded to the participant). Any food left on theparticipant's plate was placed back into the serving bowl prior toweighing.

Following the lunch meal, participants provided VAS ratings every 30minutes until 3:00 pm, at which time they went through the End ofSession Evaluation. Participants were given two paper VAS ballots totake with them for recording pre- and post-dinner ratings on the eveningimmediately following the study session. A pre-addressed, stampedenvelope was provided by Celerion for the participants to mail backtheir ballots.

The VAS rating ballot were presented on paper and consisted of four100-mm continuous line scales anchored at the left and right sides withdescriptors such as “Not at all” and “Very Strong.” The questions on theVAS rating ballot included “How strong is your desire to eat rightnow?”; “How hungry do you feel?”; “How much food do you think you couldeat right now?”; and “How full do you feel?” Participants wereinstructed to place a mark on the line for each question correspondingto their ratings. A new ballot was provided at each time point. Paperballots were provided for participants to record their ratings beforeand after dinner the evenings after the Study Sessions.

All meals were provided by the study facility. Participants were askedprior to study enrollment about their willingness to consume the foodsthat were served during the study. The Principal Investigator or his/herdesignee could disqualify any participant who responded they would noteat the indicated foods. Each participant received the same breakfast atthe same time of day (8:00 am). The meal consisted of a pre-packagedmuffin, a banana and a bottle of orange juice. Participants wereinstructed to consume the entire meal within a 30 minute timeframe.

Each participant received the same lunch at the same time of day (1:00pm). The meal consisted of pasta with marinara sauce and a bottle ofwater. Lunch was served in individual bowls for each participant thatwere weighed prior to serving (blinded to the participants).Participants were instructed to serve themselves from the bowl ontotheir plate and to eat as much as they want, to a feeling of comfortablefullness. The participants were required to finish the bottle of water.Participants were instructed to consume their meal within a 30 minutetimeframe. Participants consumed their meal in separated areas toeliminate any influence from others around them. After the participanthad finished eating, the serving bowl of food was weighed again and thetotal weight consumed was calculated and converted to kilocalories.

Test sample ingredients included (ingredient/supplier/catalog number):gelatin capsule/Capsuline/Size 00 Blue-Blue; Ground red pepper/EliteSpice/PR9458; Bloody Mary mix/Zing Zang; Natural/Artificial amarettoflavor/Mane/F94762; Red food coloring/McCormick; Brown foodcoloring/McCormick; PINNOTHIN™ TG/Stepan Lipid Nutrition; andCLEARPROTEIN™/Fonterra/Whey Protein Isolate 895. Formulations includedTest Sample A, with unfilled capsules and a shot comprising 60 ml bloodymary mix, 200 mg natural/artificial amaretto flavor, 8 drops red foodcoloring, and 4 drops brown food coloring. Formulation of Test Sample B,with 380 mg ground red pepper filled capsules and a shot comprising 60ml bloody mary mix, 200 mg natural/artificial amaretto flavor, 8 dropsred food coloring, and 4 drops brown food coloring. Formulation of TestSample C, with 380 mg ground red pepper filled capsules and a shotcomprising 60 ml bloody mary mix, 200 mg natural/artificial amarettoflavor, 8 drops red food coloring, 4 drops brown food coloring, 5 gCLEARPROTEIN™, and 3 g PINNOTHIN™ TG.

Results from this study are depicted in FIGS. 6-10. FIG. 6 is adistribution plot of desire to eat ratings with each point representingan individual participant. FIGS. 7 and 8 are graphs of desire to eatchange from baseline and desire to eat change from baseline separated bygender. FIG. 9 is a graph of food intake at lunch separated by placebo,capsaicin only, and capsaicin plus satiety drink groups. FIG. 10 showsthe correlation between food intake and desire to eat separated byplacebo, capsaicin only, and capsaicin plus satiety drink groups.Capsaicin only treatment showed the greatest decrease from baselinecompared to placebo for ratings of hunger, prospective food consumption,and desire to eat. PINNOTHIN™ and CLEARPROTEIN™ in combination withcapsaicin was not significantly different from placebo treatment.Capsaicin only treatment effect lasted for the first hour aftertreatment and showed significant correlations with food intake. Therewas an interaction between gender and treatment for the majority of thevariables, with females overall rating desire to eat and hunger lowerthan males for all treatments.

Example 3

Capsaicin was encapsulated in both inclusion complexes and entericcoating. Inclusion complexes of capsaicin with beta-cyclodextrin (1 g ofcomplex containing 5 mg of capsaicin) were formed by dispersing therequired amounts of beta-cyclodextrin and alcoholic solution ofcapsaicin in water followed by sonication. The product was recovered bydrying the solid material. Enteric coatings of capsaicin were preparedby mixing the alcoholic solution of Eudragit L-100-55 polymer andcapsaicin and drying into films/powders to produce encapsulated forms (1g of product contains 5 mg of capsaicin). This product releasescapsaicin in neutral pH but not in acidic pH of around 3. Other polymerssuch as ethyl cellulose or cellulose acetate phthalate can be used.Precipitation was performed by adding the alcoholic solution of EudragitL-100-55 polymer and capsaicin to water. The precipitated mass was driedand ground into powder. Combinations of various polymers can be used tocontrol the release profile of the active ingredient. Additional methodssuch as spray-drying may also be used. It is expected that encapsulationwill increase the shelf life of the active ingredient.

While the foregoing describes in detail a zero-calorie tonear-zero-calorie snacking product composition containing anencapsulated capsaicin-based flavor system with reference to specificembodiments thereof, it will be apparent to one skilled in the art thatvarious changes and modifications equivalents to the zero-calorie tonear-zero-calorie snacking product composition containing anencapsulated capsaicin-based flavor system may be employed, which do notmaterially depart from the spirit and scope of the invention.Accordingly, all such changes, modifications, and equivalents that fallwithin the spirit and scope of the invention as defined by the appendedclaims are intended to be encompassed thereby. All publications citedherein are incorporated by reference in their entireties for allpurposes.

1-30. (canceled)
 31. A snacking product comprising: a flavor system thatcomprises encapsulated capsaicin, an encapsulated capsaicin analogue, ora combination thereof; wherein the snacking product is a zero-calorie tonear-zero calorie snacking product; wherein the snacking product doesnot comprise capsiate; and wherein the flavor system further comprisesfood fibers.
 32. The snacking product of claim 31, wherein the snackingproduct is configured to stimulate vagal nerve endings in agastrointestinal tract.
 33. The snacking product of claim 32, whereinthe vagal nerve endings express the transient receptor potential cationchannel subfamily receptor V member 1 (TRPV1) receptor.
 34. The snackingproduct of claim 32, wherein the vagal nerve endings express thecholecystokinin (CCK) receptor.
 35. The snacking product of claim 31,wherein the encapsulated capsaicin, encapsulated capsaicin analogue, orcombination thereof is micro-encapsulated.
 36. The snacking product ofclaim 31, wherein the flavor system further comprises Korean Pine Oil.37. The snacking product of claim 31, wherein the snacking product is anenergy drink, an energy bar, a dietary supplement, a capsule, a pill, alozenge, a sub-combination thereof or a combination thereof.
 38. Thesnacking product of claim 31, wherein the snacking product is located ina screw cap of a beverage container.
 39. The snacking product of claim38, wherein the snacking product is released upon opening of the screwcap.